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Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry | Clinical Trials | Clareo Health

COMPLETED

Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

NCT02261623•Boston Scientific Corporation

Summary

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

Detailed Description

This study is designed to provide a report of these features related to the use of WallFlex metal biliary stents used per standard of practice in Canada.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject indicated for biliary metal stent placement per local standard of practice
•Age 18 or older
•Willing and able to comply with study procedures and follow-up schedule
•Willing and able to provide written informed consent to participate in study

Exclusion Criteria

•Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
•Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)

Locations (12)

Peter Lougheed Centre

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Providence Health - St. Paul's Hospital

Vancouver, British Columbia, Canada

Victoria General Hospital

Victoria, British Columbia, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Oakville-Trafalgar Memorial Hospital

Oakville, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Hopital Charles Le Moyne

Greenfield Park, Quebec, Canada

Key Dates

Start Date

March 19, 2015

Primary Completion Date

March 31, 2016

Completion Date

March 31, 2016

Last Updated

January 6, 2020

Enrollment

415

ACTUAL participants

Conditions

Biliary Strictures

Interventions

WallFlex™ Biliary RX Fully Covered Stent System RMV

DEVICE

WallFlex™ Biliary RX Partially Covered Stent System

DEVICE

WallFlex™ Biliary RX Uncovered Stent System

DEVICE

Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

NCT06614452

Biliary Strictures

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COMPLETEDNA

Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

NCT01343160

Biliary Strictures

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COMPLETED

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

NCT02698137

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Inclusion Criteria

Exclusion Criteria

Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent